What did FDA report as the most-cited issues during medical device inspections for the fiscal year of 2020? Understanding the data can help you prepare against making these common, avoidable mistakes during your next quality system inspection.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences. Together, Mike and Jon discuss the FDA FY2020 data for medical device quality system inspections and evaluate the top three most cited QSR clauses that resulted in 483 observations.

• The volume of inspections and number of findings, such as 483 observations and warning letters, were down - partially due to the COVID pandemic.
• Other reasons may include whether remote inspections are effective or even allowed. However, the number of 483s issued against medical device quality systems decreased by 50% in 2020.
• Top 3 Cited Claims: CAPAs, complaints, and design controls made up about 35% of all 483 observations issued by the FDA in 2020.
• Of the 197 times that CAPAs were issued last year, manufacturers either did not document or cite procedures. Medical device companies must have a quality management system (QMS) and follow a CAPA process to be compliant.
• CAPA should be changed to preventative and corrective actions (PACA). Put the emphasis on preventing problems, rather than correcting problems and complaints when they happen.
• Almost 200 complaints were cited because manufacturers didn’t document procedures for maintaining files.
• Also, 139 complaints were filed due to medical device failures not investigated, not containing required information, or lacking rationale to not conduct an investigation. Every complaint requires some level of investigation.
• Design validation of design controls gets most 483 observations for not having procedures, not performing or documenting risk analysis, not having software validations, or not using a production equivalent device in validation studies.



“When the number of findings is down, is it because we in companies and we as an industry are doing a better job? Or, is it because of something else?” Mike Drues

“Apparently, FDA doesn’t have a mandate or I’ll use the word, permission, or something of that nature, to do remote inspections for med device companies.” Jon Speer

“Our job as medical device professionals is to make sure that the products that we design, develop, manufacture, sell, so on and so forth, they’re as safe and effective as they can possibly be.” Jon Speer 

“I have a responsibility, certainly to the patients, to do an investigation when I learn about something.” Jon Speer

“Average regulatory professionals know the rules, but the best ones know the exceptions.” Mike Drues

The Top 10 Most-Cited Issues in FDA FY2020 Medical Device Inspections

FDA - Inspection Observations

FDA - Medical Devices

FDA - Corrective and Preventive Actions (CAPA)

FDA - Form 483 Frequently Asked Questions

FDA - Premarket Notification 510(k)

Code of Federal Regulations (CFR) - Title 21 Part 820

CFR Part 820:30 - Design Controls

The Bleeding Edge Documentary on Netflix

Mike Drues on LinkedIn

Greenlight Guru Academy

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

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